Moderna, Merck personalized mRNA cancer vaccine cuts melanoma recurrence in Phase 2 INTerpath-001
Personalized mRNA vaccines, seen as mRNA's next act beyond COVID, showed improved recurrence-free survival in melanoma, drawing broad expert commentary.
STAT · +14 outlets
FDA grants accelerated approval to Inovio's Voceryq DNA immunotherapy for recurrent respiratory papillomatosis
The clearance is the first DNA immunotherapy approved in the US; partner Precigen shares fell 27% after hours on the news.
HCPLive · +7 outlets
Japan performs world's first stem cell transplant in a patient with Parkinson's disease
The procedure marks an early clinical test of induced pluripotent stem cell therapy for a neurodegenerative disease with no disease-modifying treatment.
ProPakistani · +9 outlets
Genmab head and neck cancer bispecific cuts death risk 50% in Phase 3, shares hit record
Positive Phase 3 results lifted Genmab's market value by more than $7 billion and put oncology biotech back on retail watchlists.
Biopharmadive · +14 outlets
FDA proposes withdrawing approval of Tavneos in the US
A proposed withdrawal would remove a marketed therapy and marks an unusual regulatory reversal.
UA.NEWS · +9 outlets
Akeso posts strong clinical showing at ESMO 2026, headlining oncology readouts
The ESMO annual meeting delivered a wave of cancer drug data, with Akeso drawing particular attention from industry and investors.
Biopharmadive · +5 outlets
Pelthos Therapeutics to merge with Castle Creek Biosciences for rare skin disease therapy, up to $300M in milestones
The deal consolidates two biotechs pursuing a rare skin-disease treatment with contingent milestone payments.
Dealroom · +7 outlets
Gilead discloses partial clinical hold on two CAR-T cell therapy trials
The hold pauses parts of Gilead's CAR-T programs, adding to regulatory scrutiny of cell therapies.
Fierce Biotech · +1 outlets
Acumen scraps its sole asset after Alzheimer's trial failure, stock plunges 80%
The company is left without a pipeline candidate following the miss, wiping out most of its market value.
BioSpace · +1 outlets
FDA draft guidance would let one approval cover multiple personalized gene-editing treatments
The proposal aims to speed individualized gene therapies for rare diseases by creating a streamlined BLA pathway.
Medical Daily · +14 outlets
FDA approves first drug for Alexander disease after decades without a treatment
The approval is the first for the rare neurological disorder, and followed a family's $2 million fundraising effort for the gene therapy.
UA.NEWS · +14 outlets
Agios sickle cell drug FDA review extended to Feb. 1, 2027
The three-month extension delays a regulatory decision in a competitive sickle cell disease market.
Stock Titan · +6 outlets
Iovance adds biomarker selection to lifileucel lung cancer trial after surprise twist; stock crashes
The change to the trial design followed disappointing data, sending shares of the top-performing biotech sharply lower.
The Clinical Trial Vanguard · +3 outlets
UK clears Casgevy gene therapy for children as young as five, NHS funding unresolved
Expanded eligibility broadens access to the CRISPR-based sickle cell and beta thalassemia therapy, though reimbursement is still unsettled.
Tech Times · +4 outlets
Merck to raise next-decade revenue forecast on new drug optimism
The guidance signals confidence in Merck's pipeline as it faces patent expirations on key products.
pharma.economictimes.indiatimes.com · +2 outlets
Labor Department finalizes PBM disclosure rule requiring fee and compensation data sharing
Starting in 2027, pharmacy benefit managers must disclose fees and compensation to self-funded employer clients, drawing cheers from employers and objections fr
Biopharmadive · +7 outlets
Lilly's retatrutide beats Ozempic in head-to-head weight-loss trial
The experimental drug could be among the most potent obesity treatments developed, intensifying competition in the GLP-1 market.
Indian Pharma Post
AstraZeneca launches three-year cost-cutting program targeting $1.5B in annual savings for R&D
The savings are earmarked for reinvestment in research and development as the company restructures.
STAT